Long-Term Safety and Efficacy of Durable Polymer Cobalt-Chromium Everolimus-Eluting Stents in Patients at High Bleeding Risk

  • Sabato Sorrentino
    Mount Sinai Medical Center, New York (S.S., B.E.C., R.C., P.G., B.V., U.B., Y.L., R. Mehran).
  • Bimmer E. Claessen
    Mount Sinai Medical Center, New York (S.S., B.E.C., R.C., P.G., B.V., U.B., Y.L., R. Mehran).
  • Rishi Chandiramani
    Mount Sinai Medical Center, New York (S.S., B.E.C., R.C., P.G., B.V., U.B., Y.L., R. Mehran).
  • Paul Guedeney
    Mount Sinai Medical Center, New York (S.S., B.E.C., R.C., P.G., B.V., U.B., Y.L., R. Mehran).
  • Birgit Vogel
    Mount Sinai Medical Center, New York (S.S., B.E.C., R.C., P.G., B.V., U.B., Y.L., R. Mehran).
  • Usman Baber
    Mount Sinai Medical Center, New York (S.S., B.E.C., R.C., P.G., B.V., U.B., Y.L., R. Mehran).
  • Vinuta Rau
    Abbott Vascular, Santa Clara, CA (V.R., J.W.).
  • Jin Wang
    Abbott Vascular, Santa Clara, CA (V.R., J.W.).
  • Mitchell Krucoff
    Duke University Medical Center, Durham, NC (M.K.).
  • Ken Kozuma
    Teikyo University, Tokyo, Japan (K.K.).
  • Junbo Ge
    Zhongshan Hospital, Fudan University, Shanghai, People’s Republic of China (J.G.).
  • Ashok Seth
    Fortis Escorts Heart Institute, New Delhi, India (A.S.).
  • Raj Makkar
    Cedars-Sinai Medical Center, Los Angeles, CA (R. Makkar).
  • Yuqi Liu
    Mount Sinai Medical Center, New York (S.S., B.E.C., R.C., P.G., B.V., U.B., Y.L., R. Mehran).
  • Sripal Bangalore
    New York University Langone Medical Center (S.B.).
  • Deepak L. Bhatt
    Brigham and Women’s Hospital Heart & Vascular Center, Harvard Medical School, Boston, MA (D.L.B.).
  • Dominick J. Angiolillo
    University of Florida College of Medicine-Jacksonville (D.J.A.).
  • Shigeru Saito
    Shonan Kamakura General Hospital, Japan (S.S.).
  • Franz-Josef Neumann
    University of Freiburg, Germany (F.-J.N.).
  • James Hermiller
    St Vincent’s Medical Center of Indiana, Indianapolis (J.H.).
  • Marco Valgimigli
    Bern University Hospital, Switzerland (M.V.).
  • Roxana Mehran
    Mount Sinai Medical Center, New York (S.S., B.E.C., R.C., P.G., B.V., U.B., Y.L., R. Mehran).

書誌事項

タイトル別名
  • A Patient-Level Stratified Analysis From Four Postapproval Studies

抄録

<jats:sec> <jats:title>Background:</jats:title> <jats:p>Long-term outcomes in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention with a drug-eluting stent are unclear. Therefore, we aimed to evaluate long-term adverse events in HBR patients undergoing percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent implantation.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods:</jats:title> <jats:p>We analyzed stratified data from 4 all-comers postapproval registries. Patients with at least 1 of the following criteria were categorized as HBR: age ≥75 years, history of major bleeding (MB), history of stroke, chronic oral anticoagulant use, chronic kidney disease, anemia, or thrombocytopenia. Additionally, in a separate analysis, patients were categorized according to the recently published Academic Research Consortium HBR criteria. The Kaplan-Meier method was used for time-to-event analyses. Coronary thrombotic events (CTE) included myocardial infarction or definite/probable stent thrombosis. MB was defined according to the TIMI (Thrombolysis in Myocardial Infarction) or GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) scales. Impact of CTE and MB on subsequent risk of mortality was assessed using multivariable Cox regression with MB and CTE included as time-updated covariates.</jats:p> </jats:sec> <jats:sec> <jats:title>Results:</jats:title> <jats:p> Of the total 10 502 patients included, 3507 (33%) were identified as HBR. Compared with non-HBR patients, those at HBR had more comorbidities, higher lesion complexity, and a higher risk of 4-year mortality (Hazard Ratio [HR] 4.38 [95% CI, 3.76–5.11]). Results were qualitatively similar when using Academic Research Consortium criteria to define HBR. Risk of mortality was increased after CTE (HR 5.02 [95% CI, 3.93–6.41]), as well as after MB (HR 4.92 [95% CI, 3.82–6.35]). Of note, this effect was consistent across the spectrum of bleeding risk ( <jats:italic>P</jats:italic> -interaction test 0.97 and 0.06, respectively). </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions:</jats:title> <jats:p>Compared with the non-HBR population, HBR patients experienced worse 4-year outcomes after percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent. Both CTE and MB had a significant impact on subsequent risk of mortality irrespective of bleeding risk.</jats:p> </jats:sec>

収録刊行物

  • Circulation

    Circulation 141 (11), 891-901, 2020-03-17

    Ovid Technologies (Wolters Kluwer Health)

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